Comparison of the Effects of Internet Cognitive-Behavioral Therapy (ICBT) and Internet Acceptance and Commitment Therapy(iACT) on Mental health and Mindfulness of Medical Students
Comparison of the effect of internet cognitive-behavioral therapy (ICBT) and internet based acceptance and commitment therapy (iACT) on mental health and mindfulness of medical students of Kerman University of Medical Sciences.
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized, 2 phases on 60 people. The rand function of Excel software was used for randomization.
Settings and conduct
The current research is of an interventional type. The statistical population of this study is the medical students of Kerman University of Medical Sciences in the internship stages in 1401. This is an applied study which is conducted on 60 students with informed consent and compliance with the entry and exit criteria after receiving the permission and code of ethics, and its purpose is to compare the effect of internet cognitive-behavioral therapy (ICBT) and treatment based on Internet acceptance and commitment (iACT) on mental health and mindfulness of medical students of Kerman University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Guest students at Kerman University of Medical Sciences.
concurrent participation in another psychiatric intervention,
history of mental illness, being treated by a psychiatrist, taking psychiatric drugs,
Lack of proper access to social networks
Lack of consent to continue the treatment process.
Intervention groups
ICBT group undergoing cognitive-behavioral therapy
iACT group undergoing acceptance and commitment therapy
control group (not subjected to any treatment)
Main outcome variables
mental health, mindfulness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171009036661N5
Registration date:2023-01-16, 1401/10/26
Registration timing:registered_while_recruiting
Last update:2023-01-16, 1401/10/26
Update count:0
Registration date
2023-01-16, 1401/10/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3335 6220
Email address
m.mayel@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-12, 1401/07/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Internet Cognitive-Behavioral Therapy (ICBT) and Internet Acceptance and Commitment Therapy(iACT) on Mental health and Mindfulness of Medical Students
Public title
Comparison of the Effects of Internet Cognitive-Behavioral Therapy (ICBT) and Internet Acceptance and Commitment Therapy(iACT) on Mental health and Mindfulness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Medical students of Kerman University of Medical Sciences during internships in 2022
Proficiency in Persian language
Exclusion criteria:
Guest students at Kerman University of Medical Sciences
concurrent participation in another psychiatric intervention
history of mental illness, being treated by a psychiatrist, taking psychiatric drugs
Lack of proper access to social networks
Lack of consent to continue the treatment process
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the method of selecting people will be simple random sampling. In this way, we number the list of names of the students who are going to enter the study from 1 to the last (60) and record each of the numbers on similar and identical small cards. Then we put all the cards in a box and every time after shaking the box, we randomly take out one card from the box and record its number. We continue this process until the number of 20 people is obtained. We put these people in the ICBT group. Then, after shaking the box, we take out another 20 cards and record their number. The names of the 20 cards removed will be considered as the iACT group, and the names of the 20 cards remaining in the box will be considered as the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, main investigator and outcome assessor were blinded. The data analyser were also blinded because all checklist was without name and contained only a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-08-09, 1401/05/18
Ethics committee reference number
IR.KMU.REC.1401.202
Health conditions studied
1
Description of health condition studied
The effect of Internet Cognitive-Behavioral Therapy (ICBT) and Internet Acceptance and Commitment Therapy (iACT) on mental health and mindfulness
ICD-10 code
F48.9
ICD-10 code description
Nonpsychotic mental disorder, unspecified
Primary outcomes
1
Description
mental health
Timepoint
2 months after the start of the intervention
Method of measurement
GHQ mental health scale
2
Description
mindfulness
Timepoint
2 months after the start of the intervention
Method of measurement
Five-faceted Mindfulness Questionnaire (FFMQ)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: people undergoing Internet cognitive-behavioral therapy/ Duration of treatment: 2 months/ How to hold: online/ Number of sessions: 8 sessions (4 sessions per month)/ Duration of sessions: 1 hour/ Content: Internet cognitive-behavioral therapy according to the discretion of the expert who organized the course
Category
Behavior
2
Description
Intervention group (second): people undergoing treatment based on acceptance and commitment on the Internet/ Duration of treatment: 2 months/ How to hold: online/ Number of sessions: 8 sessions (4 sessions per month)/ Duration of sessions: 1 hour/ Content: acceptance and commitment on the Internet therapy according to the discretion of the expert who organized the course
Category
Behavior
3
Description
Control group: people who do not undergo any treatment.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Masoud Mayel
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Email
masoud.mayel@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malekpour Afshar
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Bahonar hospital, Qarani st.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department - Shahid Bahonar Hospital - Kerman - IRAN
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
masoud.mayel@gmail.co
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department - Shahid Bahonar Hospital - Kerman - IRAN
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
masoud.mayel@gmail.co
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available